Country: Canada
Language: English
Source: Health Canada
ANTITHROMBIN III (HUMAN)
TAKEDA CANADA INC
B01AB02
ANTITHROMBIN
1100UNIT
KIT
ANTITHROMBIN III (HUMAN) 1100UNIT
INTRAVENOUS
1 VIAL OF POWDER AND 20 ML VIAL OF WATER
Schedule D
DIRECT THROMBIN INHIBITORS
Active ingredient group (AIG) number: 0124256002; AHFS:
APPROVED
1999-11-08
_Antithrombin III NF (Antithrombin III (Human), E.P.) _ _Page 1 of 19_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ANTITHROMBIN III NF Antithrombin III (Human) Freeze-dried powder with diluent for intravenous injection/infusion 450 - 550 IU/10 mL AT RELEASE 900 - 1100 IU/20 mL AT RELEASE European Pharmacopoeia Anticoagulant Takeda Canada Inc. 22 Adelaide Street West, Suite 3800 Toronto Ontario M5H 4E3 Date of Initial Approval: Jul 13, 2018 Date of Revision: Apr 29, 2021 Submission Control No: 246332 TAKEDA TM and the TAKEDA Logo ® are trademarks of Takeda Pharmaceutical Company Limited, used under license. _ _ _Antithrombin III NF (Antithrombin III (Human)) _ _Page 2 of 19_ RECENT MAJOR LABEL CHANGES - NOT APPLICABLE TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED_ . _ TABLE OF CONTENTS ................................................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .............................................................................................. 4 1 INDICATIONS ...................................................................................................................................................... 4 1.1 PEDIATRICS ............................................................................................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................................................... 4 4 DOSAGE AND ADMINISTRATION ............................................................................................................... 4 4.1 DOSING CONSIDERATIONS ................................................................................................................................... 4 4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT ........................................... Read the complete document